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Regeneron Interrupts Covid-19 Trial Enrollment

[ Price : $8.95]

Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in...

Guide on Drug Standardized Study Date eSubmissions

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FDA posts a revised guidance on Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Gene Therapy, Digital Health Boost in PDUFA Talks

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FDA user fee reauthorization meetings look to advance efforts associated with its Cell and Gene Therapy Program and Digital Health...

OPDP Director Tom Abrams Retires

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CDER Office of Prescription Drug Promotion director Tom Abrams retires after 27 years at FDA.

Medtronic Pays $8.1 Million to Settle Kickback Charges

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Medtronic agrees to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to a physici...

Tricida Surprised at FDA Veverimer Comments

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Tricida says it is surprised that FDA does not believe its veverimer development program provides sufficient evidence for accelera...

FDA Using Emulate to Evaluate Covid Vaccine Safety

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FDA continues a research agreement with Emulate to use its organ-chips in studies of Covid-19 vaccines.

Medical Device Nitinol Increases Bench Testing: Analysis

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Attorney Michael Kasser says requirements in a new FDA guidance could mean that medical device companies should avoid using nitino...

Better Understanding of Heterogeneous Treatment Effects

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Panelists from FDA, universities, and private companies look at ways to better understand the heterogeneous treatment effects of d...

Biosimilar User Fee Reauthorization Meeting

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Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act program.